Build or Buy Challenge: Six Advantages of Using a Pre-Qualified, Fully Customizable GMP Environment

Sponsored by Almac

March 17, 2021

Today, biopharma companies face growing challenges when capacity is at a premium. Investment decisions must be made to ultimately determine the expansion of facilities, headcounts and technology choices necessary to maintain supply. Discover the advantages of readily available, pre-qualified GMP facilities when faced with a "build or buy" decision.

As global patient populations increase, there are a growing number of challenges and demands faced by biopharma companies to ensure their drug product is delivered in a timely and cost-effective way. When capacity is at a premium, significant investment decisions must be made to ultimately determine the expansion of existing facilities, headcounts and technology choices necessary to maintain supply.

With so many elements to consider, a clear strategy must be defined to ensure any potential investment can be maximised for the long term. However, this is not always possible due to changes in business objectives and requirements.

An alternative solution to the "build or buy" decision is the use of readily available, pre-qualified GMP facilities which can be fully tailored to suit individual company and processing needs and provide reassurance that product will be delivered on time and on budget.

Engaging with an established CDMO to provide suitable facilities to deliver valuable drug product and manufacturing of all dosage forms offers a range of clear advantages.

The following are just some of the benefits biopharma companies can leverage:

1. Flexibility

One of the ultimate benefits of utilizing pre-qualified, customizable space is that of enhanced flexibility.  Space can be configured as required to meet processing needs and can be scaled up and down as necessary.

Set-up and implementation of all equipment, technology and processes will be defined and agreed prior to commencement of operations to suit individual requirements.

2. Elimination of study delays

Often there is immediate demand which can add pressure to the product development program therefore, as time is of the essence, it is crucial to enable delivery of drug on time.  If capacity is maximized in existing facilities, plans to expand can often be challenging which will undoubtedly adversely affect timelines for supply of valuable drug product.

By utilizing pre-qualified GMP capacity via an established and experienced CDMO, operations can commence much quicker with less time required for planning agreements, construction, validation and approval.  Effectively providing a "turnkey" solution.

3. Minimize costs

Depending on short term and long-term requirements, constructing, or alternatively, purchasing a new facility to expand capacity can be extremely expensive. Additional capital investment of this nature could potentially require years of planning prior to approval which will have an effect on crucial timelines.

An agreed partnership with a suitable CDMO can save significant cost to enable investments to be made in other areas of the business as appropriate.

4. Guaranteed compliance

By utilizing pre-qualified GMP space at a credible CMO facility, full traceability is provided relating to validation, manufacturing and quality procedures.  Additional services including power, compressed air, purified water, RH control and Class 10,000/100,000 rooms are available on demand to ensure a suitable environment to accommodate specific drug product processing. 

Full auditing and inspection can be carried out prior to commencement. This offers reassurance that all operations will be performed to the highest specification throughout the entire product development program.

5. Autonomy

While equipment and technology are housed in a third party's facility, the sponsor's control will be guaranteed in order to ensure individual requirements are met throughout the project's lifecycle. Unplanned adjustments and revisions to agreed operations will be supported with authorized access available, as required, to enable continual review and supervision throughout.

6. Access to skilled employees

A reputable CDMO will have a wealth of technical expertise which can be leveraged, as required, to perform some or all operations. A wide range of highly skilled engineering, scientific and operational employees can be contracted to dedicate agreed time on individual projects. This option enables the company's own existing employees to focus on core manufacturing activities and other key projects as determined by the business.

Partnering with a reputable and experienced CDMO to extend existing capacity will prove beneficial in a variety of ways and will present an opportunity to significantly improve productivity and supply.

Departure from the build or buy paradigm and utilizing pre-qualified GMP space at a credible CDMO facility not only provides full flexibility and allows the biopharma company to benefit from the CDMOs processes, people and infrastructure to simplify manufacturing, it also provides a timely and cost-effective solution to ensure patient needs are met.


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